NCT06943534 Omalizumab Weight-Based Dosing Efficacy Trial
| NCT ID | NCT06943534 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Allergies |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-07-03 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Eligibility Criteria
Inclusion Criteria: * A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (peanut, cashew, walnut, egg, or milk) * Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods * A positive history of clinical reaction to at least one of the qualifying foods other than the challenge-qualifying food (If meeting above criteria): * Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg) Exclusion Criteria: * Weight \>80 kg at time of screening * Clinically significant laboratory abnormalities at screening. * Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab. * Poorly controlled or severe asthma/wheezing at screening * History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise requiring intubation. * Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of screening. * Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers. * Past or current history of eosinophilic gastrointestinal disease within three years of screening. * Past or current history of cancer, or currently being investigated for possible cancer. * Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6 months of screening. * Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening. * Inability to discontinue antihistamines for minimum wash-out periods required for SPTs or OFCs. * Pregnant or breastfeeding or intending to become pregnant during the study. * Evidence of clinically significant chronic disease.
Contact & Investigator
Wayne Shreffler, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06943534 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 55 Years, studying Allergies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06943534 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06943534 currently recruiting?
Yes, NCT06943534 is actively recruiting participants. Contact the research team at Jgill@mgh.harvard.edu for enrollment information.
Where is the NCT06943534 trial being conducted?
This trial is being conducted at Boston, United States, Chapel Hill, United States, Dallas, United States.
Who is sponsoring the NCT06943534 clinical trial?
NCT06943534 is sponsored by Massachusetts General Hospital. The principal investigator is Wayne Shreffler, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 30 participants.